The HipSextant Instrument is a manual mechanical acetabular positioning device. The devices is used in conjunction with CT mapping of the individual patients pelvis. The instrument has three legs which land on the pelvis. The legs form three points which define the sextant plane. The sextant has two protractors that are adjusted to orientate a direction pin in the direction of the desired orientation of the acetabular component. During surgery a small pin is placed into the ischium and a cannulated leg and the sextant are seated onto the ischium. The second leg is seated onto the lateral side of the anterior spine by placing an arthroscopic style trocar through a cannula. Finally, a third leg is also seated using a trocar. With the sextant firmly docked onto the pelvis, the cup impactor is then aligned with the sextant direction pin. The device is used with an Excel spreadsheet which is used to assist the surgeon in performing calculations regarding alignment.

AI/ML Overview

The provided text describes a 510(k) submission for the Hip Sextant Instrument System, a manual surgical instrument used to align acetabular components during hip arthroplasty procedures. However, the document does not contain the specific information required to complete all parts of your request regarding acceptance criteria and a study proving those criteria are met.

Here's what can be extracted and what information is missing:

Missing Key Information:

Specific Acceptance Criteria: The document mentions "successfully passed clinical and nonclinical testing" but does not define any specific quantitative acceptance criteria for device performance (e.g., accuracy of alignment in degrees, precision, error margins).
Detailed Study Design and Results: While "clinical experience" and "validation of software" are listed as tests, there are no details about study design, participants, comparative effectiveness, or specific numeric results that would allow for a table of acceptance criteria vs. reported performance.
Sample sizes (test set and training set): Not mentioned.
Data provenance: Not mentioned.
Number of experts/qualifications: Not mentioned.
Adjudication method: Not mentioned.
MRMC study information: Not mentioned.
Effect size of AI assistance: Not applicable as this is a mechanical device, not an AI system.
Standalone performance: Not applicable in the context of AI. The device is a "manual mechanical acetabular positioning device" implying it's used by a surgeon.
Type of ground truth: Not mentioned.
How ground truth for training set was established: Not mentioned.

Based on the provided text, here is what can be inferred or directly stated:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred/General)	Reported Device Performance (General)
Biocompatibility	"The subject device is composed of medical grade biocompatible materials."
Sterilization Efficacy	"The subject device has been subjected and successfully passed clinical and nonclinical testing including... Sterilization Validation"
Cleaning Efficacy	"The subject device has been subjected and successfully passed clinical and nonclinical testing including... Cleaning Validation (including protein residual)"
Durability/Repeated Use	"The subject device has been subjected and successfully passed clinical and nonclinical testing including... Repeated autoclave studies to evaluate performance and wear"
Software Functionality (for calculations)	"The subject device has been subjected and successfully passed clinical and nonclinical testing including... Validation of software used in conjunction with the device to perform calculations." (The device is used with an Excel spreadsheet for calculations).
Clinical Use (Safety & Effectiveness)	"The subject device has been subjected and successfully passed clinical and nonclinical testing including... Clinical experience." The submission concludes: "We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate devices." (No specific quantitative performance metrics like alignment accuracy are provided.)
Substantial Equivalence to Predicate Devices	"Surgical Planning Associates, Inc. believes that the subject device is substantially equivalent to the cited predicate devices. ...the conclusion of substantial equivalency is based on the identical indications for use, design concept, level of surgical invasiveness, and that all cited instruments are metal and reusable. Equivalence is further substantiated by clinical and nonclinical data."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified for any of the validations or clinical experience.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not specified. The document mentions "clinical experience" but does not detail how ground truth was established or by whom.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC Study: Not applicable/not performed as this is a mechanical surgical instrument, not an AI or imaging diagnostic device.
Effect Size of AI assistance: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable as this is a manual mechanical device, not an algorithm/AI. The device is explicitly stated to be a "manual mechanical acetabular positioning device" used "in conjunction with CT mapping" but actively manipulated by a surgeon.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not specified. The general statement "clinical experience" does not elaborate on the type of ground truth used to assess performance.

8. The sample size for the training set

Not applicable/not specified. This is a mechanical device, not an AI system that requires a "training set" in the machine learning sense. The "validation of software" implies software testing, but a "training set" for the device itself is not relevant here.

9. How the ground truth for the training set was established

Not applicable/not specified, as there is no "training set" in the context of this mechanical device.

Summary

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510(k) Summary

Device: Hip Sextant Instrument System (K093491)

Submission Type: Traditional 510(k)

DEC - 9 2010

Date Prepared [21 cFR 807.92(a)(1)]: Revised October 29, 2010

Submitter's Information [21 CFR 807.92(a)(1)]

This 510(k) is being submitted by Orchid Design on behalf of Surgical Planning Associates, Inc.

Contact:

Curtis Raymond Orchid Design 80 Shelton Technology Center - Shelton, CT 06484 Tel: (203) 922-0105 - Fax: (203) 922-0130 e-mail: curt.raymond@orchid-orthopedics.com

Sponsor / Manufacturer:

Surgical Planning Associates, Inc 43 Riverside Avenue, #192 Medford, MA 02155

FDA Establishment Registration#: Pending

Trade Name, Common Name, Classification (21 CFR 807.92(1)(2)) Device Trade Name: Hip Sextant

Device Common, Usual, or Classification Names:

Orthopedic Stereotaxic System .
. Acetabular cup alignment guides
Acetubular Positioner ●
Socket positioned .
. Trocar

Classification: Class 2; ref. 21 CFR 21 §882.4560 (OSF – Patient Specific Manual Orthopedic Stereotaxic System).

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Predicate Devices [21 CFR 807.92(a)(3)]

Wright Medical Acetabular Alignment Guide, Class 1 Exempt .
Depuy Pinnacle Cup System Class 1. Exempt .
Stryker Acetabular Alignment Guide, Class 1 Exempt .
Aufranc Universal Cup Alignment Guide Class 1 Exempt and . Preamendment
Protractors Class 1 exempt and Pre-amendment .

The subject device as well as the predicate devices are composed of medical grade metal and reusable. The Depuy, Stryker, and Wright Medical instruments were design to be used with hip systems from the respective manufacturers. Both the Hip Sextant and the Aufranc Universal Cup Alignment Guide can be used during any hip reconstructive procedure regardless of the type of implant being used.

Both the HipSextant device and Protractors have measurement numbers or indicators on the device to assist the surgeon with alignment. The other devices do not have such numeric indicators.

Description of the Device [21 CFR 807.92(a)(4)]

The HipSextant Instrument is a manual mechanical acetabular positioning device. The devices is used in conjunction with CT mapping of the individual patients pelvis.

The instrument has three legs which land on the pelvis. The legs form three points which define the sextant plane. The sextant has two protractors that are adjusted to orientate a direction pin in the direction of the desired orientation of the acetabular component.

During surgery a small pin is placed into the ischium and a cannulated leg and the sextant are seated onto the ischium. The second leg is seated onto the lateral side of the anterior spine by placing an arthroscopic style trocar through a cannula. Finally, a third leg is also seated using a trocar. With the sextant firmly docked onto the pelvis, the cup impactor is then aligned with the sextant direction pin.

The device is used with an Excel spreadsheet which is used to assist the surgeon in performing calculations regarding alignment.

Intended Use [21 CFR 807.92(a)(5)]

The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures.

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Technological Characteristics [21 CFR 807.92(a){6}}

Surgical Planning Associates, Inc. believes that the subject device is substantially equivalent to the cited predicate devices. These types of devices are typically exempt from 510(k). However, the subject device utilizes a nontraditional plane for the navigation of acetabular cup positioning, which we believe can be appropriately reviewed under a 510(k) notification. Nevertheless, the conclusion of substantial equivalency is based on the identical indications for use, design concept, level of surgical invasiveness, and that all cited instruments are metal and reusable. Equivalence is further substantiated by clinical and nonclinical data.

Performance Data [21 cFR 807.92(b)(1)]

The subject device is composed of medical grade biocompatible materials.

The subject device has been subjected and successfully passed clinical and nonclinical testing including the following:

Sterilization Validation ●
Cleaning Validation (including protein residual) .
· . Repeated autoclave studies to evaluate performance and wear
Validation of software used in conjunction with the device to perform ● calculations.
Clinical experience .

Conclusion 121 CFR 807.92(b)(3)1

We believe the subject device is substantially equivalent to the predicate device and conclude that the subject device is as safe and effective as the predicate devices.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Surgical Planning Associates % Orchid Design Mr. Joseph Azary 80 Shelton Technology Center Medford, Massachusetts 02155

DEC - 9 2010

Re: K093491

Trade/Device Name: Hip Sextant Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OSF Dated: November 05, 2010 Received: November 08, 2010

Dear Mr. Azary:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be clevice is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to Conninered prices that have been reclassified in accordance with the provisions of the Federal Food, Drug. devices mat have been recuire approval of a premarket approval appiroval appin&ation (PMA). and Cosmetic Act (Act) that do not require to the general controls provisions of the Act. The You may, dicierore, market the devices, editories and the coursely of the productions of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adultieration. Ticase note: CDTCP doos not be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (500 acove). Existing major regulations affecting your device can be may be subject to addinonal controls. Encluding on Janes 800 to 898. In addition, FDA may
found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition found in the Code of I ederal Regarations)
publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Prease be advised that I DA s issuation of a bucking of a backless with other requirements of the Act

{4}------------------------------------------------

Page 2 - Mr. Joseph Azary

or any Federal statutes and regulations administered by other Federal agencies. You must or any Federal statutes and regulations administered of ot registration and listing (21
comply with all the Act's requirements, including, but norsting of medical comply with all the Act 's requirements, merce reporting (reporting of medical
CFR Part 807); labeling (21 CFR Part 801); medical device reguirements as CFR Part 807); labeling (21 CFR Part 807); pood manufacturing practice requirements as set
device-related adverse events) (21 CFR 803); good manufacturing practices the elect device-related adverse evenis) (21 CFR Pat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, the elec forth in the quality systems (QS) regulation (21-51-14) of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
s (1580) html (1980) (1992) (1988) (1988) (1988) (1980) hm for If you desire specific advice for your device on our called fires/ucm liness and lises of Compliance . Also deast go to http://www.da.gov/AboutrDA/Cchices of Compliance Also, please
the Center for Devices and Radiological Health's (CDRH's) Office of Compliance of CDLCFP Part the Center for Devices and Radiongical riculties of the consemarket notification" (21 CFR Part
note the regulation entitled, "Misbranding by reference varies vegalation (2 note the regulation entitled, "Misolanding of relevelse to premiers
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

CFR Part 803), please go to 110,://www.rad.governma.government of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the You may obtain other general information. on your Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 030-2641 01 (30) ijicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

incerely yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name:

Indications for Use:

K09 349/

Hip Sextant Instrument System

The Hip Sextant Instrument System is a manual surgical instrument used to align the acetabular components during hip arthroplasty procedures.

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Niel Reiden Gorman

Page 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

K093491 510(k) Number ________________________________________________________________________________________________________________________________________________________________

DEC - 9 2010

Page 3

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).